Combination enhanced therapy

ABSTRACT

A Positive Airway Pressure (PAP) device includes a flow generator that generates a supply of pressurized air. The flow generator includes a programmable controller. The programmable controller is adapted to allow continuous access to at least one active operating mode and selective access to at least one dormant operating mode. The programmable controller includes a mode control system adapted to receive a data signal to control the selective access to the at least one dormant operating mode.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/148,055, filed Jan. 6, 2014, now allowed; which is a continuation ofU.S. application Ser. No. 11/707,160, filed on Feb. 16, 2007, now U.S.Pat. No. 8,640,697, which claims the benefit of U.S. ProvisionalApplication No. 60/774,222, filed Feb. 17, 2006, which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a Positive Airway Pressure (PAP) devicefor ventilatory assistance and, more particularly, to a PAP device thatprovides at least one operating mode present in a dormant state.

BACKGROUND OF THE INVENTION

A Positive Airway Pressure (PAP) device is used in the treatment ofsleep related breathing disorders such as Obstructive Sleep Apnea (OSA).Colin Sullivan was the first to invent the use of nasal ContinuousPositive Airway Pressure (CPAP) to treat Obstructive Sleep Apnea (OSA),e.g., see U.S. Pat. No. 4,944,310. OSA is characterized by partial orcomplete occlusion (i.e., apnea) of the upper airway passage duringsleep. OSA sufferers repeatedly choke on their tongue and soft palatethroughout the entire sleep period resulting in lowered arterial bloodoxygen levels and poor quality of sleep.

CPAP treatment generally provides a supply of air or breathable gas froma blower to a patient via an air delivery conduit and a patientinterface, such as a full-face or nasal mask or nasal prongs. The air orbreathable gas is commonly delivered at a pressure of 4 cmH₂O to 28cmH₂O and acts as a splint to hold the airway open during sleep. CPAPtherapy has been shown to effectively eliminate both snoring andobstructive sleep apneas. However, some patients complain of discomfortwith CPAP therapy.

The pressure required for effective CPAP therapy differs betweenpatients. In order to determine an individual's effective CPAP therapypressure, the individual generally undergoes a sleep study in ahospital, clinic or sleep laboratory. A complete sleep study commonlyoccurs over two nights, with diagnosis of OSA occurring the first nightand pressure titration occurring the second night. On the first night,the individual is observed while asleep and parameters such as oxygensaturation, chest wall and abdominal movement, air flow, expired CO₂,ECG, EEG, EMG and eye movement are recorded. On the second night, theindividual is provided with nasal PAP therapy and the deliveredtreatment pressure is altered in response to the presence of snoring orapneas. The minimum pressure required during the night to eliminate thesnoring and apneas is determined to be the effective PAP therapypressure.

Because breathing against a pressure elevated above ambient pressure canbe uncomfortable, especially when trying to sleep, it is desirable tokeep the PAP pressure as low as practicable, particularly if theindividual requires long term treatment. Lower PAP pressures also resultin a lower mask contact pressure which is generally more comfortable forthe user. Thus, during PAP therapy it is desirable to use the lowestpracticable treatment pressure that is effective in preventing occlusionin order to provide the higher levels of comfort and thereby promotecompliance with treatment.

Another type of CPAP device known as a Bilevel CPAP device provides afirst pressure during inhalation (commonly termed an IPAP) and a second,lower pressure during exhalation (commonly termed an EPAP). Somepatients perceive that the lower pressure during exhalation is morecomfortable, at least while they are awake. Examples of these devicesinclude the ResMed VPAP® series, and the Respironics BiPAP® series.Bilevel CPAP devices may be prescribed for patients who are notcompliant with single pressure CPAP devices.

A further type of CPAP mode designed to enhance patient comfort andcompliance provides a rapid decrease in pressure at the beginning ofexpiration and then quickly returns to therapeutic pressure at or nearthe end of expiration. These algorithms are designed to overcome theperceived problem of exhaling against a high pressure and are termedExpiratory Pressure Relief (EPR) modes. This mode forms the basis ofRespironics C-Flex mode. See published applications WO 2005/065757 andWO 2004/112680 and U.S. Pat. Nos. 5,535,738; 5,794,625; 6,105,575;6,609,517 and 7,128,069.

Another way of improving patient comfort and compliance is to start eachtherapy session at a low therapeutic pressure (e.g., 4 cmH₂O), and thenramp up to full therapeutic pressure over a period of time such as thefirst hour. This allows the patient to adjust to the sensation whilefalling asleep. Alternatively, the device may be set to implement a timedelay before full therapeutic pressure is applied, which allows thepatient time to fall asleep before full therapeutic pressure is applied.See U.S. Pat. Nos. 5,199,424 and 5,522,382.

Another form of CPAP therapy can be provided by an automaticallyadjusting CPAP device such as the ResMed AUTOSET™ SPIRIT™ device. Inthis device, the CPAP pressure is automatically increased or decreasedin accordance with indications of flow limitation, such as flowflattening, snore, apnea and hypopnea. See U.S. Pat. Nos. 5,704,345;6,029,665; 6,138,675; and 6,363,933. These patents also describe amethod and apparatus for distinguishing between so-called “central” andobstructive apneas. More recently, automatically adjusting Bileveldevices have been described where both the IPAP and the EPAP pressuresare capable of being automatically increased or decreased in accordancewith indications of flow limitation as described above. See pendingpatent application WO 2005/063323.

An advantage of an automatically adjusting system is that it providesthe patient with an elevated PAP only when required. This means that thepatient is spared the discomfort of receiving the highest treatmentpressure during the whole treatment session. Furthermore, while thetreatment pressure required for a particular patient may vary over time,a correctly functioning automatic system can obviate the need for thepatient to return for a subsequent sleep study to reset the treatmentpressure delivered by the PAP device.

Generally, PAP devices are made and tested to work most efficiently withparticular patient interface systems. However, the PAP devices andpatient interface systems are sold as separate components of the therapyequipment. Thus, patients may decide to use a particular PAP devicetogether with a patient interface system that was not specificallytested for that PAP device. This may result in a less than efficienttherapy system. Therefore, a system that encourages consumers to buycompatible products may provide more efficient and/or comfortabletherapy. Once compatible products are combined, they may deliverenhanced therapy benefits compared to the separate products alone.

The contents of all of the aforesaid patents are incorporated herein bycross-reference.

The present invention provides improvements to known PAP devices toenhance and/or facilitate the treatment session.

SUMMARY OF THE INVENTION

An aspect of the present invention is to provide a Positive AirwayPressure (PAP) device including a flow generator that generates a supplyof pressurized air. The flow generator includes a programmablecontroller. The programmable controller is adapted to allow continuousaccess to at least one active operating mode and selective access to atleast one dormant operating mode. The controller includes a mode controlsystem adapted to receive a data signal to control the selective accessto the at least one dormant operating mode.

Another aspect of the invention is to provide a patient interface systemadapted to generate or otherwise provide a data signal that is adaptedto activate a dormant operating mode present within a PAP device. Forexample, the data signal may be generated by or obtained from aproximity switch present in a patient interface connector or a radiofrequency identification (RFID) tag present on the patient interfacesystem.

A further aspect of the invention is to provide an electronic chip orcard including a data signal that is adapted to activate a dormantoperating mode present within a PAP device. The electronic chip orelectronic card is adapted to communicate with the mode control systempresent in the PAP device.

The PAP device may further include at least one continuously availableactive operating mode. In an embodiment, the continuously availableactive operating mode is a Continuous Positive Airway Pressure (CPAP)mode.

The at least one dormant operating mode that is activated by a datasignal may include any known PAP mode, e.g., an auto-adjusting pressuremode and/or an Expiratory Pressure Relief (EPR) mode.

Alternatively, the data signal may include a pin or code number that isinserted into the device using a user input unit, such as a keypad. Inan embodiment, the pin or code number is input into the device via atelephone or Internet connection. The pin or code number may comprisenumbers, letters and/or symbols or any combination thereof.

In an embodiment the dormant operating mode is activated for apredetermined time period. The predetermined time period is controlledby a clock that is activated by the data signal. The clock may countdown or up a predetermined amount of time. The clock may count inreal-time or the clock may count the patient compliance or device usagetime such as hours of usage.

The dormant operating mode may be capable of repeated activation byobtaining new data signals.

Yet another aspect of the invention relates to a method for configuringa PAP device. The method includes programming the PAP device with atleast one primary therapy delivery mode and at least onerestricted-access dormant therapy delivery mode, and enabling access tothe at least one dormant therapy delivery mode only upon receipt of anactivation signal, command, and/or code.

Still another aspect of the invention relates to a method forencouraging the purchase of a PAP device and a peripheral component froma common supplier. The method includes programming the PAP device fromthe common supplier to operate in at least one primary therapy deliverymode and at least one restricted-access dormant therapy delivery modethat can be activated only upon receipt of an activation signal, code,or command, and enabling operation of the PAP device in the at least onedormant therapy delivery mode upon operative connection with theperipheral component from the common supplier that is associated withthe activation signal, code, or command.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a perspective view of a flow generator system according to anembodiment of the invention; and

FIG. 2 is a flow diagram showing an overview of an embodiment of thecombination enhanced therapy process.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

1.1 PAP Device

FIG. 1 illustrates a PAP device or flow generator system 10 according toan embodiment of the present invention. As illustrated, the PAP device10 includes a flow generator having a motor-driven impeller 12 thatprovides a supply of pressurized air for the administration of CPAPtreatment. The pressurized air is delivered to a patient via a patientinterface 14. An air delivery conduit 16 is coupled between the PAPdevice 10 and the patient interface 14. A programmable controller 18controls the operations of the flow generator. The PAP device 10 maycomprise a user interface unit 20 to allow information input and adisplay unit 22 to display output information.

In an embodiment, the PAP device 10 includes at least two operatingmodes programmed into the programmable controller 18 at the time ofmanufacture. A first operating mode, termed the active operating mode,would be continuously available for use. The active operating mode maybe a basic operating mode such as CPAP pressure mode, which deliverspressurized gas at a constant set pressure. A second operating mode,termed the dormant operating mode, would be present in the device in aninactive or dormant state such that the second operating mode is notfreely available for use. The dormant operating mode would requireactivation from a data signal. The data signal would provide anactivation signal to a mode control system 34 that is in communicationwith the programmable controller 18 and would enable operation of thedormant operating mode. The PAP device 10 may provide more than twooperating modes with one or more operating modes being continuouslyavailable and one or more dormant operating modes requiring activation.

1.2 Patient Interface System

The patient interface 14 may have any suitable configuration as is knownin the art, e.g., full-face mask, nasal mask, oro-nasal mask, mouthmask, nasal prongs, etc. Aspects of the invention may be used with bothvented and non-vented masks and single or dual tube breathing gas supplysystems.

1.3 Data Signal

The data signal 32 is capable of sending a signal to the mode controlsystem 34 to enable activation of a dormant operation mode presentwithin the PAP device 10. The mode control system 34 provides the accesssignal to activate a dormant operating mode present within the PAPdevice 10. The data signal 32 may be delivered to the mode controlsystem 34 in the PAP device 10 using any appropriate device or system.

For example, in one embodiment, the data signal 32 may be carried by anelectronic card or chip that is inserted into the PAP device 10 toprovide the data signal 32 to the mode control system 34. In anotherembodiment, the dormant operating mode may be activated by inputting aspecific pin number into the PAP device 10. The pin number would providethe data signal 32 to the mode control system 34 to subsequentlyactivate the at least one dormant operating mode. The pin number may beinput into the device 10 via the user input unit 20 or the pin numbermay be obtained or input into the device via a telecommunicationsconnection such as a telephone line or the Internet. This later optionmay assist in preventing multiple machines from using the same pinnumber to activate the dormant operating mode by maintaining a record ofpin numbers used and preventing further use. In an embodiment, the modecontrol system 34 may destructively read the data signal 32 to preventrepeated use of the data signal 32 to activate multiple devices.

In an alternative embodiment, the data signal 32 may be incorporatedinto a patient interface system. The connection of the patient interfacesystem, including the air delivery conduit 16, to the PAP device 10would provide the data signal 32 to the mode control system 34 toactivate the at least one dormant operating mode. For example, thepatient interface system and PAP device 10 may comprise proximityswitches (e.g., magnetic reed switches), such as those described inResMed's co-pending U.S. provisional application No. 60/707,950 to Kwoket al. filed 15 Aug. 2005, the entirety incorporated herein byreference. The proximity switches would provide a data signal toindicate the type of components being used. Such a data signal may alsoprovide to the PAP device 10 the appropriate flow characteristics forthe component connected together with the data signal to allow use ofthe dormant operating mode.

Alternatively, other forms of connector or component recognition may beused as discussed in ResMed's co-pending U.S. provisional applicationNo. 60/656,880 filed 1 Mar. 2005, the entirety incorporated herein byreference. For example, the patient interface system may comprise aradio frequency identification (RFID) tag that provides a data signal 32to the mode control system 34 present in the PAP device 10. In thisembodiment, the mode control system 34 present in the PAP device 10 is aRFID scanner that detects the data signal 32 and activates the dormantoperating mode.

1.4 Dormant Operating Mode

The at least one dormant operating mode present within the PAP device 10may include any known PAP operating mode, for example, an automaticadjusting (AutoSet®) mode, Bilevel mode, an automatic Bilevel modeand/or an Expiratory Pressure Relief type operating mode. There may be aseries of different data signals, such as electronic chips or smartcards, that each activates a different dormant operating mode presentwithin the PAP device 10.

As noted above, the dormant operating mode may be an automaticallyadjusting (AutoSet®) operation mode. An AutoSet® mode would provide anenhanced level of comfort to the user of the PAP device as the deliveredpressure is commonly lower than those provided by a CPAP device set todeliver the maximum pressure requirement. In an embodiment, the AutoSetoperating mode may be provided using a low cost system that does notrequire the use of sophisticated sensors, e.g., using thesession-by-session adjusting device as described in ResMed's applicationPCT/AU2005/000174 filed 10 Feb. 2005, the entirety incorporated hereinby reference. Alternatively, the PAP device may use the algorithmic flowestimator system described in ResMed's U.S. provisional application Nos.60/624,951 filed 4 Nov. 2004 and 60/625,878 filed 8 Nov. 2004, theentirety of each being incorporated herein by reference. A similarmethod is described in WO2004/067070, which is assigned to SAIME S A,the entirety incorporated herein by reference. It is understood that anymethod of providing an automatically adjusting operation mode or otherPAP operation modes are encompassed within the scope of the presentinvention.

FIG. 2 shows an overview of an embodiment of the combination enhancedtherapy process. A basic PAP device 10 is connected to a patientinterface system 40. The basic PAP device 10 would provide access to abasic CPAP operating mode 42. However, if the patient interface systemcomprises a data signal or a separate data signal is provided, then thebasic PAP device 10 is enabled to allow access to an AutoSet® therapymode (dormant operating mode) 44. In the illustrated embodiment, uponaccess being allowed to the AutoSet® therapy mode 44, a clock would beinitiated at 46. The clock 46 may activate the dormant operating modefor a limited time period. In an embodiment, the limited time periodwould relate to the life of a patient interface system and may, forexample, be between three and twelve months, e.g., six months. However,other time periods are encompassed within the scope of the invention.

The limited time period of operation for the activated dormant operatingmode may be controlled by starting a clock that counts or monitors aparameter related to time or usage of the activated operating mode. Forexample, the clock may simply count down or up to a predetermined limitusing a calendar type of system. In this regard, the operating modewould only be provided for a set period of time regardless of whetherthe device was used or not. Alternatively, the clock may allow apredetermined number of hours of use of the activated dormant operatingmode, thus the clock would count the numbers of hours of usage and oncethe limit was reached the activated operating mode would be inactivatedagain (see FIG. 2). There may also be different data signals thatprovide different amounts of operating time.

In one embodiment, the PAP device 10 would check whether the time limitset by the data signal had been reached at 48 prior to beginning of eachtherapy session. Therapy using the AutoSet® therapy mode (dormantoperating mode) 44 would only commence if the time limit was below thepredetermined limit. If the time limit was equal to or above thepredetermined limit, then the PAP device would register the time limitas expired and prevent further access to the dormant operating mode.Thus, only allowing use of the basic CPAP operating mode 42.

Alternatively, the basic PAP device may regularly check the clockthroughout the therapy session. If the time limit has not been reached,then access to the AutoSet® therapy mode (dormant operating mode) 44would be maintained. However, once the time limit is reached, the accessto the dormant operating mode would expire and the PAP device wouldrevert to only delivering the basic CPAP operating mode 42.

In a further embodiment, the PAP device would include a ‘sleepout’feature that enabled the current therapy session to continue. The‘sleepout’ feature would prevent patient discomfort or arousal fromsleep due to the dormant operating mode switching to the basic CPAP modewhile a patient was sleeping. Thus, if the time limit expires during atherapy session, then the dormant operating mode would not immediatelycease, but rather one or more of the following may apply:

-   -   a. the device would remain in the activated dormant operating        mode until the therapy session ended; or    -   b. the device would remain in the activated dormant operating        mode for a further preset time. The duration of that preset time        may be fixed (e.g., for five hours) or capable of being adjusted        (e.g., be adjustable between the range of 4 to 10 hours).        Alternatively, the preset time may be established by reference        being made to the average duration of preceding therapy periods.        For example, a calculation is made of the average therapy        session duration for the preceding (e.g., five) therapy        sessions. To avoid calculation of an undesirably low preset        time, a default session time may be included to take precedence        over an undesirably short preceding therapy session. For        example, should a preceding therapy session be of less than five        hours duration, then a default period of five hours will be        substituted for that session in the calculation of the average.        The calculated average would be set as the preset time that        would apply for the continuance of the availability of the        dormant operating mode only during the session in which the time        limit set by the data signal expires.

As illustrated in FIG. 2, the dormant operating mode may be capable ofrepeated activations by further data signals 50. The further datasignals may be provided by purchasing further patient interface systems.The data signal would again allow access to the AutoSet® therapy mode 44and the process would be repeated. Each further activation of thedormant operating mode by a data signal would initiate a newpredetermined time period of operation of the dormant operating mode.

In a further embodiment, the PAP device would inform the user that thesystem had changed from dormant operating mode to basic CPAP mode. Thismay be achieved by way of a message appearing on a visual display, anauditory signal and/or communications transmitted by wireless orhardwired networks to a computer. The system may provide a reminder tothe user that it is time to replace the patient interface system and/orto obtain a new data signal. In an embodiment, the device may provide areminder to the user prior to the expiration of the predetermined timelimit. The message may also provide instructions to the user on the useof the device and contact details of a clinician or other healthcareprofessional.

In the default setting, the PAP device would provide basic PAP operatingfunctions. The addition of a data signal, for example present on anelectronic chip or card, an RFID tag or pin code, would provide accessto enhanced functionality in the form of the dormant operating modepresent within the PAP device. The data signal is read by the modecontrol system, which then allows access to the dormant operating mode.In one embodiment, the mode control system would routinely look at thedata signal location, for example, every ten seconds or minute. If avalid data code is detected, then access to the dormant operating modeis enabled or continued. If no data signal is detected or an invaliddata code is detected, then the dormant operating mode remains dormant,as access is denied.

In another embodiment, the mode control system may destructively readthe data signal and enable access to the dormant operating mode for apredetermined amount of time. Thus, the mode control system may activatea clock that counts the predetermined time for use of the dormantoperating mode. Once the predetermined time has expired, the signal maybe turned off and the PAP device may revert to default settings ofproviding basic PAP therapy. In an embodiment, the mode control systemmay be pre-programmed to recognize a set of data signals. In a furtherembodiment, the mode control system may be capable of receiving softwareupgrades to allow further pre-programming to recognize additional datasignals.

1.5 Packaging of the Data Signal

The data signal required to activate the dormant operating mode in a PAPdevice may be packaged with a compatible patient interface system toencourage the purchase of the compatible patient interface systems. Theelectronic chip, electronic card, pin or code number or any other datasignal device may be provided within the patient interface packaging orissued at the time of purchase of the patient interface system.Alternatively, as discussed previously, the data signal is in-built withthe patient interface system.

Further aspects of the invention may include the addition ofnon-therapeutic benefits that may be linked to the continued use ofparticular types of patient interface systems (i.e., a customer loyaltyprogram). If a patient were to display continuous use of particulartypes of patient interface systems, then the access to the dormantoperating mode therapy may be extended for longer periods of time. Forexample, after 3 replacement masks, the dormant operating mode may beactivated for 8 months instead of 6 months. Alternatively, thecontinuous use of particular types of patient interface systems may earn“loyalty points” that may be used for discounts on products or services.The quantity of these “loyalty points” may be reported by a coded valueappearing on the LCD or via a Smartcard system. This system may alsoadvantageously provide data on the buying patterns of customers,provided each patient interface system style and size was uniquelycoded, that may assist in company management and planning. It may alsoprovide sale organizations with some history of the patient interfacesystems used by a returning customer such that they could identifypotential new patient interface systems for the customer to try if a newmodel or improved version became available.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. In addition, while the invention hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, barriatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

What is claimed is:
 1. A Positive Airway Pressure (PAP) devicecomprising: a flow generator configured to generate a supply ofpressurized air, the flow generator including a programmable controller;wherein the programmable controller is configured to allow access to atleast one pre-stored first positive pressure operating mode and toprevent access to at least one pre-stored second positive pressuresoperating mode until receipt of a data signal, and wherein the datasignal is provided to the programmable controller to enable or activateonly selective access to the at least one second operating mode.
 2. ThePAP device according to claim 1, wherein the at least one first activeoperating mode is a Continuous Positive Airway Pressure (CPAP) mode. 3.The PAP device according to claim 1, wherein the at least one secondoperating mode is an automatically adjusting pressure mode.
 4. The PAPdevice according to claim 1, wherein the at least one second operatingmode is an Expiratory Pressure Relief (EPR) mode.
 5. The PAP deviceaccording to claim 1, wherein the data signal is present on anelectronic chip or card.
 6. The PAP device according to claim 5, whereinthe electronic chip or card is insertable into a signal receivingportion within the flow generator to provide the data signal to theprogrammable controller to at least temporarily enable or activate thesecond operating mode.
 7. The PAP device according to claim 1, whereinthe data signal is a pin or code number.
 8. The PAP device according toclaim 7, wherein the flow generator includes a user input unit and thepin or code number is insertable using the user input unit.
 9. The PAPdevice according to claim 8, wherein the user input unit is a keypad.10. The PAP device according to claim 7, wherein the pin or code numberis receivable by the device via a telephone or Internet connection. 11.The PAP device according to claim 7, wherein the pin or code numberincludes numbers, letters and/or symbols or any combination thereof. 12.The PAP device according to claim 1, wherein the data signal is presenton a patient interface system, and wherein the attachment of the patientinterface system to the flow generator is configured to provide the datasignal to the programmable controller to enable or activate the at leastone second operating mode for a predetermined period of time.
 13. ThePAP device according to claim 12, wherein the data signal is a proximityswitch present in a patient interface connector.
 14. The PAP deviceaccording to claim 12, wherein the data signal is a radio frequencyidentification (RFID) tag present in the patient interface system. 15.The PAP device according to claim 1, wherein the programmable controllerincludes a clock that is activated by the data signal and controls apredetermined period of time.
 16. The PAP device according to claim 1,wherein the at least one second operating mode is repeatably activatableby a data signal.
 17. An electronic card or chip comprising a datasignal configured to temporarily enable or activate a dormant operatingmode present within a PAP device, the dormant operating mode beingdifferent from one or more continuously available operating modespresent in the PAP device, both the dormant operating mode and the oneor more continuously available operating modes being suitable fortreating a patient over the course of a therapy session.
 18. A methodfor configuring a PAP device, the method comprising: beingpre-programming the PAP device to operate in accordance with at leastone primary therapy delivery mode and at least one restricted-accessdormant therapy delivery mode; and enabling access to the at least onedormant therapy delivery mode only upon receipt of an activation signal,command, and/or code.
 19. The method according to claim 18, furthercomprising providing a mode control system to the PAP device to receivethe activation signal, command, and/or code to control access to the atleast one dormant therapy delivery mode.
 20. The method according toclaim 18, further comprising providing the activation signal, command,and/or code on an electronic chip or card.